Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and
the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with
relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow
their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets
for 24 weeks. Individuals will continue with their current treatments in addition to
following the study diet.

The study requires four visits to the University of Iowa Hospitals and Clinics in Iowa City,
Iowa. Visits will be 12 weeks apart. Study activities include fasting blood draws, weighed
food records, motor and cognitive testing, physical activity assessment, questionnaires, and
daily diet checklists while following the study diet. Some reimbursement available.

Inclusion Criteria:

- Willing to allow your neurologist to sign a letter confirming multiple sclerosis
diagnosis and criteria used in diagnosis

- Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria
confirmed by their treating neurologist

- Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4

- Between the ages of 18 and 70

- Body Mass Index greater than or equal to 19

- Ability to shop for and prepare or have someone in the family shop for and prepare
home cooked meals according to study diet guidelines

- Willingness to keep detailed food records

- Willing to eat a diet that includes more vegetables and excludes many comfort foods
such as those made with white flour,

- Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated
fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1
tablespoon per day

- Must not be pregnant or planning to become pregnant in the next year

- Willing to eat meat (eg, chicken, turkey, fish)

- Willingness to follow either the Wahls Elimination diet or the Swank diet

- Individuals who have had gastric bypass surgery have obtained a signed statement from
their physician indicating they are weight stable and a suitable candidate for this
study

- Normal or mild cognitive impairment as measured by the Short Portable Mental Status
Questionnaire

- Willing to have blood drawn

- Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in
one hand)

Exclusion Criteria:

- Taking insulin or Coumadin

- Relapse within past 12 weeks

- Treatment for a cancer (other than skin cancer) currently or in the prior 12 months

- Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones,
psychiatric disease likely to make adherence to the study interventions more difficult
including eating disorders, but excluding depression and anxiety

- Body Mass Index less than 19

- Moderate to severe mental impairment as measured by the Short Portable Mental Status
questionnaire

- Inability to shop for and prepare home cooked meals by the subject or a companion

- Unwillingness to eat meat

- Participation in another research study that involves multiple sclerosis or other
medications, diet, supplement, exercise or other treatments

- Inability to keep food records with sufficient detail to asses dietary intake or
complete study questionnaires

- Unwilling to have blood drawn

- Pregnant or planning to become pregnant in the next year